Validation of a Novel Foot Offloading Device
Keywords
Abstract
Description
All subjects will receive the PopSole™ offloading device at the screening/baseline visit, be asked to wear it for 4 weeks, and will be asked to return for an in-person evaluation at week 2 and a completion study visit at week 4.
Screening includes the following procedures:
1. Performance of a limited physical exam, inclusive of participant's foot exam with a gait and shoe gear evaluation.
2. Medical and surgical history collection
3. Vital signs, medication profile, allergies, height, weight, and BMI calculation.
4. Collection of demographic information
5. 2D Photographs of both feet will be performed
Subjects will be asked to complete:
1. Questionnaires
- Foot and Ankle Ability Measure questionnaire
- Mayo Clinical Scoring System questionnaire
- American Orthopaedic Foot and Ankle Society questionnaire
- Manchester Foot and Ankle Disability Index
- Pittsburgh Foot Survey
2. Diary cards to document for the feet: pain, bruising, redness of the skin, itching, swelling, bleeding, and any concerns/issues not listed, as well as the location, date and day for each noted symptom.
3. Offload Device Distribution. Devices will be provided for both feet to maintain symmetry and gait stability between the two feet. One pair of devices will be given for use in shoe gear, and one pair will be given for use in a slide in the shower.
Follow up visit procedures:
Week 2
1. Collection of vital signs, medication profile, weight, and BMI calculation
2. Limited physical exam with a foot exam
3. Adverse Event Reporting
4. Collection and distribution of feet diary cards
5. 2D Photographs of both feet
6. Foot Assessment Questionnaires
7. Device survey - questions about the fit and feel of the device
Week 4
The same procedures listed for week 2, with the addition of PopSole™ Device removal and final foot diary card collection.
Dates
| Last Verified: | 06/30/2020 |
| First Submitted: | 05/03/2020 |
| Estimated Enrollment Submitted: | 05/03/2020 |
| First Posted: | 05/06/2020 |
| Last Update Submitted: | 07/09/2020 |
| Last Update Posted: | 07/13/2020 |
| Actual Study Start Date: | 07/31/2020 |
| Estimated Primary Completion Date: | 05/31/2021 |
| Estimated Study Completion Date: | 11/30/2021 |
Condition or disease
Intervention/treatment
Device: PopSole™ offloading device
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Experimental: PopSole™ offloading device This is an external insole device that fits into a shoe and is reusable for a given subject, not for one-time use. It is comparable to other off-the-shelf insoles readily available and presents minimal risk to the participant during the four weeks of study participation. | Device: PopSole™ offloading device Specifically, the PopSole™ Offloading Device allows the provider to pop bubbles in the device (like popping paper or plastic bubble sheeting), thereby offloading the surgical area or area of pain. This customizable approach to offloading may increase compliance as it can easily fit in a normal walking shoe and is personalized for each patient. It can also be attached to a slide for use in the shower. Currently no post-operative devices for offloading the foot can be used in the shower. |
Eligibility Criteria
| Ages Eligible for Study | 18 Years To 18 Years |
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | Yes |
| Criteria | Inclusion Criteria: 1. Aged 18 years or older and able to provide informed consent 2. Subjects with foot pain due to forefoot or heel fat pad atrophy or chronic plantar fasciitis as defined by heel pain for greater than 6 months and failed non-surgical therapy 3. Willing and able to comply with follow up examinations Exclusion Criteria: 1. Concurrent injury to the lower extremity that would effect gait 2. Open foot ulcerations, fractures, or diagnosis of osteomyelitis of the feet 3. Surgical foot intervention in the last 6 months 4. Diagnosis of pregnancy or the intent of the participant to become pregnant during participation in this study 5. Neuropathy 6. Any issue that per the physician's determination would render the patient not appropriate to continue participation in the study (compliance, change in physical status, etc.) |
Outcome
Primary Outcome Measures
1. Change in foot pain from screening visit to week 4 visit as reported on the Pittsburgh Foot Survey. [Four Weeks]
2. Change in foot pain from screening visit to week 4 visit as reported on the Manchester Foot and Ankle Index. [Four Weeks]
3. Change in foot pain from screening visit to week 4 visit as reported on the Mayo Clinical Scoring System Questionnaire. [Four Weeks]
4. Change in foot pain from screening visit to week 4 visit as reported on the American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Scale. [Four Weeks]
5. Device durability [Four weeks.]
6. Participant compliance with device [Four Weeks]
Secondary Outcome Measures
1. Participants' reported satisfaction and/or difficulties with the device. [Four Weeks]
